BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 3152932 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01367
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 4, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE PROGRAMMER WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT IT BOOTED UP SLOWLY. ANALYSIS ALSO FOUND A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER TAKES UP TWO MINUTES FROM POWER ON TO DEVICE ID SCREEN. FOLLOWUP INFORMATION RECEIVED INDICATES THE PROGRAMMER FUNCTIONED NORMALLY ONCE IT BOOTED UP. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255891 CARELINK PROGRAM W/TELEMETRY C PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1